TEST ITEMS | SPECIFICATION | RESULTS |
Description | : White or Almost White Crystalline Powder | White Powder |
Identification | : A.B. | Positive |
Assay | : 97.0~102.0% | 98.70% |
Specific Rotation | : +104°~+112° | +107.8° |
Loss On Drying | : 1.0%max | 0.36% |
Chromatographic Purity | : single impurity:1.0%max | <1.0% |
total impurities:2.0%max | <2.0% | |
Organic Volatile Impurities | : meets the requirement. | Conforms |
Residual Solvents | : meets the requirement. | Conforms |
Conclusion |
The specification conform with USP30 standard |